Main description:

Clinical trials at the confirmatory stage of drug development typically require a large number of patients recruited by many clinical centers. The design of multi-center clinical trials consists of several interconnected stages including patient recruitment planning, choosing a randomization scheme and a statistical method for analyzing patient responses on different treatments, and planning the drug supply to satisfy patient demand in different centers and regional depots. This book concentrates on the discussion of the novel analytic statistical techniques for modeling and predicting patient recruitment, randomization and drug supply processes in multi-center clinical trials, provides practical recommendations and many examples using real-life case studies and simulation in R.

Contents:

Introduction Chapter 1. Basic statistical concepts in clinical trials Chapter 2. Models for patient recruitment in multicentre clinical trials Chapter 3. Predictive patient recruitment modelling Chapter 4. Event prediction in clinical trials with waiting time to response Chapter 5. Statistical models in multicentre clinical trials Chapter 6. Modelling randomization effects Chapter 7. Drug supply predictive modelling Chapter 8. Risk-based supply modelling tool Chapter 9. Modelling & simulation examples Index